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IMP Labelling

IMPs (including placebos) are required to be labelled for ‘use in clinical trials’.  Labelling of an IMP is intended to ensure protection of the participant and traceability, enable identification of the product and trial and facilitate proper use of the investigational medicinal product1.  

The labelling of IMPs for clinical trial use is considered to be manufacture according to Directive 2001/20/EC2 a site undertaking IMP labelling activities must therefore have an MIA(IMP) licence and the IMP will subsequently need to be QP released for clinical trial use.

The Commission's 'Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial' (CT-1) requires the submission of sample trial labelling as part of the application for a Clinical Trial Authorisation (CTA).

Template IMP label for CTA application

Annex 13 of Volume 4 of the Rules Governing Medicinal Products in the EU: Good Manufacturing Practice sets out the information that should be included on IMP labels.

Template IMP labels should be prepared by the IMP manufacturer/supplier in consultation with the Chief Investigator and sponsor.

The sponsor representative will review and authorise (sign and date) the template label prior to its inclusion in the CTA application.

Label exemptions

For a trial where the IMP to be used is an authorised product and the risk assessment has determined that a normal dispensing label is appropriate then the addition of a clinical trial label is not necessary. The labelling requirements are reduced (the trial is label exempt) and the IMP can be provided by pharmacy under normal prescribing. This would be a Type A trial, where the IMP has a marketing authorisation in the UK and is being used within the terms of that marketing authorisation and has not been repackaged for use in the trial. 

Where exemption from the need for trial specific labelling under the provisions of Regulation 46 of SI 2004 No 1031 is being requested, a statement to this effect should be prepared by the Chief Investigator for inclusion in the CTA application.

Revisions to label

Any revisions to labels after the CTA is approved may constitute a substantial amendment. The Chief Investigator should discuss any revisions with the Noclor Sponsor Representative.  

An IMP is often provided and QP certified in its final form, however there may specific situations where labelling post-QP certification is required (for example, application of revised expiry date). Any requirements for labelling post-QP certification will be clearly instructed by the sponsor to participating sites.  

[1] Reference MRC/DH/MHRA Joint Project Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products.  Version 10th October 2011

[2] There are exceptions to this requirement under Regulation 37 of the Clinical Trial Regulations 2004, SI 2004 1031 as amended.